The European Commission proposed, on Tuesday 24 October, a package of measures aimed at better preventing and mitigating critical shortages of medicines in the EU this winter, next winter and in the longer term.
Recent critical shortages, particularly of certain antibiotics last winter, show that coordinated action is needed to address supply challenges and make medicine supply chains more resilient in the long run.
The communication on this subject focuses on the most critical medicines, for which security of supply in the EU must be ensured at all times.
A number of measures have already been taken to prepare for this winter. The European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) have identified key antibiotics (including specific paediatric formulations) for which they anticipate the risk of critical shortages ahead of the winter. Measures have been put in place to guarantee the availability of these antibiotics.
However, the Commission does not believe that this is the end of the matter and suggests the following actions:
- launch of a European Voluntary Solidarity Mechanism for medicines (October 2023): “This will allow any Member State facing shortages to ask for help from other Member States, which may be able to share medicines if they have sufficient supply”, explained the Commissioner for Health, Stella Kyriakides.
- establishment of a Union list of critical medicines (by the end of 2023): this list will be the first step to analyse the supply chain of selected medicines by April 2024. The analysis will show where further action is needed;
- Member States will be able to use regulatory exemptions to allow medicines to reach patients in a timely manner (by extending shelf-life or the quick authorisation of alternatives);
- drawing up EU guidance on procurement of medicines, to strengthen security of supply (the Commission will publish them at the beginning of 2024);
- EU joint procurement of antibiotics and treatments for respiratory viruses for next winter.
“We will also work with Member States to anticipate in a coordinated way elements from the pharmaceutical reform”, said the Commissioner, who referred to earlier notification of shortages by companies, shortage prevention plans for all medicines and increased information sharing on shortages at EU level.
The Commission is also advocating a Critical Medicines Alliance (operational by early 2024), which will enable national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at EU level against shortages of medicines and to address supply chain vulnerabilities.
Link to the communication: https://aeur.eu/f/980 (Original version in French by Lionel Changeur)